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Floret ASD Registry(Floret ASD Occluder is a self-expandable, double-disc device made from a Nitinol wire mesh)

A retrospective, single-arm, multicenter, observational, registry study to evaluate the safety and performance of Floret(TM) Atrial Septal Defect Occluder in a real-world setting. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/086644
Enrollment
263
Registered
2025-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: Nil: Nil Intervention2: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who have been treated with Floret(TM) Atrial Septal Defect Occluder

Exclusion criteria

Exclusion criteria: Patients who have not been treated with Floret(TM) Atrial Septal Defect Occluder

Design outcomes

Primary

MeasureTime frame
1.Successful closure 2.Technical implant success 3.Post-procedural complicationsTimepoint: 1.Time Frame: Intra-operative 2.Time Frame: Intra-operative, through 1 month, 3 months, 6 months, 1 year 3.Time Frame: Post-operative—

Secondary

MeasureTime frame
1.Occluder displacement 2.Atrial fibrillation 3.Serious adverse events/Adverse events 4.Ease of useTimepoint: 1.Time Frame: Post-operative 2.Time Frame: Intra-operative 3.Time Frame: Postoperative, through 1 month, 3 months, 6 months, 1 year 4.Time Frame: Intra-operative—

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026